DYNAGEN MINI ICD VR D020

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-30 for DYNAGEN MINI ICD VR D020 manufactured by Boston Scientific Corporation.

Event Text Entries

[185746936] It was reported that this implantable cardioverter defibrillator (icd) exhibited right ventricular (rv) noise, oversensing, possible pacing inhibition, decreased pacing and shock impedance measurements, inappropriate anti-tachycardia pacing (atp), and an inappropriate shock. It was noted that the noise appeared to be from an external source. Troubleshooting options were discussed. No adverse patient effects were reported. The device remains in service.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2124215-2020-01604
MDR Report Key9901597
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-03-30
Date of Report2020-03-30
Date of Event2018-03-27
Date Mfgr Received2020-01-27
Device Manufacturer Date2016-02-15
Date Added to Maude2020-03-30
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactTIMOTHY DEGROOT
Manufacturer Street4100 HAMLINE AVENUE NORTH
Manufacturer CitySAINT PAUL MN 55112
Manufacturer CountryUS
Manufacturer Postal55112
Manufacturer Phone6515826168
Manufacturer G1BOSTON SCIENTIFIC CORPORATION
Manufacturer StreetCASHEL ROAD
Manufacturer CityCLONMEL
Manufacturer CountryEI
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDYNAGEN MINI ICD VR
Generic NameIMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
Product CodeLWS
Date Received2020-03-30
Model NumberD020
Catalog NumberD020
Lot Number210319
Device Expiration Date2018-02-05
OperatorLAY USER/PATIENT
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC CORPORATION
Manufacturer Address4100 HAMLINE AVENUE NORTH SAINT PAUL MN 55112 US 55112


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-30

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